Enlighten Study: The EV-ICD Post Approval Registry

Active, not recruitingOBSERVATIONAL
Enrollment

1,000

Participants

Timeline

Start Date

September 1, 2023

Primary Completion Date

May 31, 2030

Study Completion Date

October 31, 2037

Conditions
Ventricular ArrhythmiaTachycardia
Interventions
DEVICE

Defibrillation using EV-ICD

Device: Defibrillation using the Extravascular ICD (EV-ICD)

Trial Locations (131)

1200

Cliniques Universitaires Saint-Luc, Brussels

4031

Universitätsspital Basel, Basel

8011

Christ Church Hospital, Christchurch

10032

New York-Presbyterian Hospital Columbia University, New York

10065

New York - Presbyterian Hospital / Weill Cornell Medical Center, New York

10305

Northwell Health Staten Island University Hospital, Staten Island

11030

Northwell Health North Shore University Hospital, Manhasset

11040

Long Island Jewish Medical Center, New Hyde Park

11706

Northwell Health South Shore University Hospital, Bay Shore

11743

Northwell Health Huntington Hospital, Huntington

12601

Hudson Valley Heart Center, Poughkeepsie

15213

University of Pittsburgh Medical Center UPMC Presbyterian, Pittsburgh

15232

University of Pittsburgh Medical Center UPMC Shadyside, Pittsburgh

15237

University of Pittsburgh Medical Center UPMC Passavant, Pittsburgh

17822

Geisinger Medical Center, Danville

18018

Saint Luke's University Health Network, Bethlehem

18711

Geisinger Wyoming Valley Medical Center, Wilkes-Barre

20162

Azienda Ospedaliera Ospedale Niguarda Cà Granda, Milan

21159

King Fahad Armed Forces Hospital, Jeddah

21801

TidalHealth Peninsula Regional, Salisbury

22908

University of Virginia Medical Center, Charlottesville

27710

Duke University Medical Center (DUMC), Durham

28277

Elektrophysiologie Bremen - Im Klinikum Links der Weser, Bremen

30060

Wellstar Research Institute, Marietta

32207

Baptist Health, Jacksonville

32405

Cardiovascular Institute of Northwest Florida, Panama City

33604

Hôpital Haut-Lévêque - CHU de Bordeaux, Pessac

33756

Clearwater Cardiovascular Consultants, Clearwater

34232

Intercoastal Medical Group, Sarasota

37203

Saint Thomas Research Institute, Nashville

38138

The Stern Cardiovascular Foundation, Memphis

40205

Norton Heart and Vascular Institute, Louisville

43210

The Ohio State University Wexner Medical Center, Columbus

43214

OhioHealth Research Institute (OHRI), Columbus

44093

Hôpital Guillaume et René Laënnec - CHU de Nantes, Nantes

44195

Cleveland Clinic, Cleveland

45219

The Christ Hospital Health Network CRD, Cincinnati

47630

Deaconess Specialty Physicians, Newburgh

48197

Michigan Heart, Ypsilanti

48912

Sparrow Clinical Research Institute, Lansing

53215

Aurora Cardiovascular Services, Milwaukee

55407

Minneapolis Heart Institute Foundation, Minneapolis

55433

Metropolitan Cardiology Consultants, Coon Rapids

55455

University of Minnesota Medical Center Fairview, Minneapolis

55905

Mayo Clinic, Rochester

59037

Centre Hospitalier Régional Universitaire de Lille, Lille

63003

Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied, Clermont-Ferrand

63110

Washington University School of Medicine, St Louis

64111

Saint Luke's Health System, Kansas City

66160

University of Kansas Medical Center Research Institute, Kansas City

72076

Eberhard Karls Universität Tübingen - Universitätsklinikum Tübingen, Tübingen

75093

Baylor Research Institute, Plano

75226

Consultants in Cardiology (Fort Worth), Dallas

76104

Heart Center of North Texas, Fort Worth

78705

Texas Cardiac Arrhythmia Research Foundation, Austin

87106

Presbyterian Heart Group, Albuquerque

92093

University of California San Diego, San Diego

93003

Cardiology Associates Medical Group, Huntington Park

94062

Sequoia Hospital, Redwood City

94305

Stanford Hospital & Clinics, Stanford

06102

Hartford Hospital, Hartford

50266-8209

Iowa Heart Center, West Des Moines

02114-2621

Massachusetts General Hospital, Boston

02115

Brigham and Woman's Hospital, Boston

08053

Virtua Health, Marlton

07962

Atlantic Health System, Morristown

10016-4972

NYU Langone Medical Center, New York

337232-8802

Vanderbilt University Medical Center, Nashville

Unknown

LKH - Universitätsklinikum Graz, Graz

Aö Landeskrankenhaus - Universitätskliniken Innsbruck, Innsbruck

Kepler Universitätsklinikum Med Campus III, Linz

Allgemeines Krankenhaus - Universitätskliniken Wien, Vienna

AZ Sint Jan Brugge-Oostende av, Bruges

McGill University Health Centre (MUHC), Montreal

Nemocnice Na Homolce, Prague

Rigshospitalet, Copenhagen

Odense Universitetshospital, Odense

Helsinki University Hospital, Helsinki

Centre Hospitalier Universitaire de Grenoble - Site Nord, La Tronche

OC Santé - Clinique du Millénaire, Montpellier

Hopital Pitie-Salpetriere AP-HP, Paris

Hôpital Européen Georges Pompidou, Paris

Institut Mutualiste Montsouris, Paris

CHU de Rennes - Hôpital Pontchaillou, Rennes

CHRU de Tours - Hôpital Trousseau, Saint-Avertin

Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum, Bad Oeynhausen

Medizinische Hochschule Hannover, Hanover

Robert-Bosch-Krankenhaus, Stuttgart

Hippokration General Hospital of Athens, Athens

George Papanikolaou General Hospital, Thessaloniki

Prince of Wales Hospital, Hong Kong

Semmelweis Egyetem AOK, Budapest

Shaare Zedek Medical Center, Jerusalem

Sheba Medical Center, Ramat Gan

Azienda Ospedaliera - Universitaria Consorziale Policlinico di Bari, Bari

Policlinico Di Sant Orsola Malpighi, Bologna

Centro Cardiologico Monzino, Milan

Azienda Ospedaliera San Gerardo, Monza

Chest Disease Hospital, Kuwait City

Amsterdam UMC - Locatie AMC, Amsterdam

Medisch Spectrum Twente, Enschede

Universitair Medisch Centrum Groningen, Groningen

Leids Universitair Medisch Centrum (LUMC), Leiden

St Antonius Ziekenhuis, Nieuwegein

Erasmus Medisch Centrum, Rotterdam

HagaZiekenhuis - Locatie Leyweg, The Hague

Slaskie Centrum Chorob Serca, Zabrze

Centro Hospitalar de Lisboa Ocidental, E.P.E. Hospital de Santa Cruz, Carnaxide

Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE, Lisbon

King Faisal Specialist Hospital & Research Centre, Riyadh

Hospital Universitario da Coruña, A Coruña

Hospital Universitari Bellvitge, Barcelona

Hospital Universitario Reina Sofía, Córdoba

Hospital Universitari de Girona Doctor Josep Trueta, Girona

Hospital Universitario Virgen de las Nieves, Granada

Hospital Universitario Son Espases, Palma de Mallorca

Hospital Universitario y Politécnico La Fe, Valencia

Sahlgrenska Universitetssjukhuset, Gothenburg

Skånes Universitetssjukhus, Skåne

Inselspital - Universitätsspital Bern, Bern

Centre Hospitalier Universitaire Vaudois, Lausanne

Istituto Cardiocentro Ticino, Lugano

UniversitätsSpital Zürich, Zurich

Glenfield Hospital, Leicester

Kings College Hospital NHS Foundation Trust, London

T2N2T9

University Of Calgary, Calgary

H1T1C8

Montreal Heart Institute, Montreal

G1V4G5

Institut Universitaire de Cardiologie et de Pneumo, Québec

61-848

Uniwersytecki Szpital Kliniczny w Poznaniu, Poznan

02-097

Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego, Warsaw

04-628

Narodowy Instytut Kardiologii - Stefana kardynała Wyszyńskiego, Warsaw

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Medtronic

INDUSTRY

NCT06048731 - Enlighten Study: The EV-ICD Post Approval Registry | Biotech Hunter | Biotech Hunter